21 C.F.R. · Food and Drugs
21 C.F.R. § 801.20

Label to bear a unique device identifier.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 801.20 — Label to bear a unique device identifier.

§ 801.20 Label to bear a unique device identifier. (a) In general. (1) The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of this subpart and part 830 of this chapter. (2) Every device package shall bear a UDI that meets the requirements of this subpart and part 830 of this chapter. (b) Exceptions. Exceptions to the general rule of paragraph (a) of this section are provided by §§ 801.30, 801.45, and 801.128(f)(2), and § 801.55 provides a means to request an exception or alternative not provided by those provisions. [78 FR 58818, Sept. 24, 2013]

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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BS-CFR21-SEC-403A33
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21 C.F.R. § 801.20
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The regulatory text of 21 C.F.R. § 801.20 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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